Screen-Printed and Thermoformed Antenna for Single Use Monitoring Devices

Embodiments of the subject matter disclosed herein relate to antennas for wireless monitoring devices and systems.

Monitoring physiological parameters of a patient is an important part of patient care, and physicians often desire to continuously monitor multiple physiological parameters of their patients. For example, well-known parameters of patient health include blood pressure, oxygen saturation (SpO2), and features of the electrocardiogram (ECG). Patient monitoring often involves the use of several sensing devices to perform multiple physiological monitoring modalities, such as a pulse oximeter, a blood pressure monitor, a heart monitor, a temperature monitor, etc. Many patient monitoring devices offer multi-modality patient monitoring, where multiple different sensing devices for sensing different physiological parameters can be connected to a single patient monitor that is configured to collect, process, and/or display physiological information describing the patient's health condition. As a result, a number of sensing devices used to collect and transmit patient data within a hospital environment may be large.

The patient monitor may be connected to wireless network accessible in the hospital environment such that the multiple different sensing devices may communicate with the patient monitor wirelessly. Additionally, a caregiver may monitor physiological patient data of the patient remotely by viewing data of the patient monitor via a remote viewing application (e.g., on a smart phone) as the patient or the caregiver move around a hospital environment. Transmitting physiological patient data from a sensor placed on a patient to the patient monitor may rely on a radio communication antenna of the sensor, which may be coupled to the sensor for transmission of the data. As a result, the large number of sensing devices in use in a typical hospital environment demand an equally large number of antennas. The antennas and the sensing devices themselves may be single use devices that are disposed of after data collection has ended.

Because each antenna is made of a conductive material crefully shaped to resonate on a specific frequency range, a cost of manufacturing the large number of antennas may be high. Additionally, antennas of different sizes, shapes, or configurations may be used for different types of sensors, data, or environments. The complexity entailed by supporting the different sizes, shapes, or configurations may further increase the antennas'manufacturing cost.

The current disclosure at least partially addresses one or more of the above identified issues by a method for manufacturing a medical device, such as a diagnostic or monitoring device, the method comprising printing an electrical path on a substrate material using a conductive ink; thermoforming a section of the substrate material including the electrical path using a mold, to create a hollow, non-flat shape; and electrically connecting the electrical path to integrated circuitry of the medical device; wherein the electrical path included on the thermoformed section of the substrate material comprises an antenna relied on by the integrated circuitry to transmit or receive physiological, diagnostic, and/or imaging signal information. In one example, the medical device is a wireless patient monitoring device including a sensor that acquires physiological patient data, and the thermoformed section is used to enclose and protect the integrated circuitry. In another example, the medical device is a measurement coil of a magnetic resonance imaging (MRI) apparatus, which is thermoformed to follow a contour of a surface of a body of a subject of the MRI apparatus.

It should be understood that the summary above is provided to introduce in simplified form a selection of concepts that are further described in the detailed description. It is not meant to identify key or essential features of the claimed subject matter, the scope of which is defined uniquely by the claims that follow the detailed description. Furthermore, the claimed subject matter is not limited to implementations that solve any disadvantages noted above or in any part of this disclosure.

6 8 FIGS.- 6 8 FIGS.- show example configurations with relative positioning of the various components. If shown directly contacting each other, or directly coupled, then such elements may be referred to as directly contacting or directly coupled, respectively, at least in one example. Similarly, elements shown contiguous or adjacent to one another may be contiguous or adjacent to each other, respectively, at least in one example. As an example, components laying in face-sharing contact with each other may be referred to as in face-sharing contact. As another example, elements positioned apart from each other with only a space there-between and no other components may be referred to as such, in at least one example. As yet another example, elements shown above/below one another, at opposite sides to one another, or to the left/right of one another may be referred to as such, relative to one another. Further, as shown in the figures, a topmost element or point of element may be referred to as a “top” of the component and a bottommost element or point of the element may be referred to as a “bottom” of the component, in at least one example. As used herein, top/bottom, upper/lower, above/below, may be relative to a vertical axis of the figures and used to describe positioning of elements of the figures relative to one another. As such, elements shown above other elements are positioned vertically above the other elements, in one example.are shown to scale, although other relative dimensions may be used, if desired.

9 10 FIGS.and The following description relates to the wireless transmission of data from devices worn by patients, such as sensors of a wireless patient monitoring system, which rely on antennas integrated into the devices. It should be appreciated that while the systems and methods proposed herein are generally described with respect to a patient monitoring system, in other examples, the systems and methods may also be used with different types of medical or other devices used to transmit or receive wireless data, such as, for example, a body coil of a magnetic resonance imaging (MRI) system, as described in relation to.

Patient monitoring may include a number of different physiological monitoring devices, sensors, etc. capable of monitoring cardiac, respiratory, neurologic, hemodynamic, pulse oximetry, etc. parameters such as but not limited to electrocardiography (ECG), peripheral capillary oxygen saturation (SpO2), respiration rate, temperature, blood pressures, entropy, blood glucose, and carbon dioxide. Patient monitoring is performed by way of many different forms and approaches with respect to data capture and communication technologies (e.g., hard-wired and wireless networking) and may include monitoring a patient locally (e.g., in-room wired or tethered to a monitor) and/or wirelessly (e.g., in-room, while in transport, ambulating telemetry). In addition to moveable roll stand and room-based semi-fixed or permanently mounted physiological patient data acquisition equipment acquiring one or more parameters, monitoring may be performed with small, portable devices (whether as multiple separate sensors or as an integrated acquisition device) coupled to the patient in order to enable the patient to ambulate (e.g., walk) remotely relative to a designated hospital bed or treatment room while maintaining monitoring of the condition of the patient (e.g., heart rhythm, oxygenation, and other patient vital signs). For example, ambulation of the patient may be desirable for resolution of various medical conditions for which the patient is being treated (e.g., chest pain, syncope, post-surgical). A care provider (e.g., nurse, doctor, or another clinician) may view an output of the monitoring device(s) on the device's user interface, at a remote location such as a patient monitoring central station, via another method such as an Electronic Medical Record (EMR) system, or at a handheld device throughout the duration that the monitoring device(s) is attached or coupled to the patient.

The patient monitor may be connected to a wireless network. The wireless network may further include a patient information database and/or other devices by which medical professionals may access and monitor patient data. Patient monitoring may include receiving physiological patient data from one or more sensors (e.g., sensing components) placed on the patient and displaying the physiological patient data on a patient monitor, and/or uploading the physiological patient data to hospital information systems via a wireless network. Once the physiological patient data has been uploaded to the hospital information systems, the physiological patient data may be transmitted to other devices such as a caregiver device for remote viewing.

The physiological patient data may be transmitted wirelessly from a sensor of the one or more sensors to the other devices via an electrical (radiofrequency) antenna coupled to the sensor. Thus, each sensor used to acquire physiological patient data from each patient may rely on a dedicated electrical antenna. The sensors and/or the antennas may be single-use devices, which are disposed of when the physiological patient data is no longer acquired. Because a number of patients being wirelessly monitored in a health care system may be large, the wireless monitoring may rely on a large number of such disposable devices. However, manufacturing metal electrical antennas at high volume may be costly.

To reduce a cost of manufacturing a high volume of electrical antennas, a method is disclosed herein for manufacturing a low-cost, high-volume electrical antenna by screen-printing a conductive ink on a flat substrate material (e.g., a film). The screen-printed substrate material may then be thermoformed into a hollow, three-dimensional (3D) shape for use in biomedical monitoring and instrumentation devices. In particular, electronics of the biomedical monitoring and instrumentation devices may be advantageously enclosed and housed within the hollow 3D shape. By manufacturing the antennas in this manner, antenna structures that can be customized for a type of sensor, type of data, or type of system may be manufactured at low cost, in large quantities. The disclosed method may also minimize a demand for additional parts, since the thermoformed substrate can simultaneously act as a device enclosure and/or structural support. The minimization of parts also reduces a weight of the antennas, and a size of an end product including a sensor may be decreased. The screen printed and thermoformed antennas may be used with patient monitoring sensors such as pulse oximetry, body temperature, electrocardiographic and respiratory rate sensors, and/or other types of sensors, and/or other types of wireless devices.

The thermoforming allows for creating various antenna geometries, including, but not limited to, dipole, monopole and loop antennas. An electrical two-dimensional path of the antenna may first be screen printed using a conductive ink, such as a silver ink, on a thermoformable plastic sheet, such as polycarbonate, polystyrene or polyethylene terephthalate. After printing, the ink may be partially or totally cured prior to the thermoforming phase, or the ink may be cured by the heat of the thermoforming process. During the thermoforming phase, the sheet may be heated and stretched over a mold, after which a vacuum may be generated at a first side of (e.g., underneath) the heated sheet. An over-pressure may be applied on a second, opposite side (e.g., a top side) of the sheet to further increase a precision and robustness of the thermoforming. After the thermoformed sheet is cooled and removed from the mold, the thermoformed sheet may be bonded to a second plastic sheet to form enclosures in which a sensor or integrated circuitry, such as a printed circuit board assembly, may be placed, or may be bonded to the integrated circuitry itself.

1 FIG. 100 100 102 106 106 100 108 110 110 110 108 108 108 110 Referring now to the figures,shows an example patient monitoring environment, which in the depicted example is a patient room in a hospital or other medical facility. Patient monitoring environmentincludes a patientbeing monitored and attended to by a clinician. Clinicianmay be a nurse, physician, medical technologist, or another suitable medical professional. Patient monitoring environmentfurther includes a patient monitorcommunicably coupled to a patient monitoring device. Patient monitoring devicemay monitor one parameter or more than one parameter. Due to differing patient conditions and varying patient monitoring demands, one or more patient monitoring devicesmay be used to support the monitoring demands of the patient and to support monitoring under various conditions (e.g., in room, in transport, patient ambulation, etc.). In some examples, the one or more patient monitorsmay be included or mounted in a floor, table top, or roll stand module that includes one or more leads or other components coupled to the patient or in wireless communication to a device connected to the patient, in order to monitor one or more parameters of the patient (such as ECG, respiration, blood pressure, carbon dioxide levels, etc.), where the one or more patient monitorsmay be configured to remain in the patient room. In other examples, the one or more patient monitorsmay be portable handheld devices that can be carried around a hospital environment by a patient or clinician, which may connect wirelessly to one or more patient monitoring devices.

110 110 110 102 Patient monitoring devicemay include one or more telemetry devices (with different sensor capabilities) housed in a common module (as shown) or housed in two or more separate modules. Patient monitoring devicemay be positioned on a body of the patient. Patient monitoring deviceincludes one or more sensors connected to the patientvia one or more leads or other components, in order to monitor one or more parameters of the patient (such as ECG, respiration, blood oxygen level, etc.).

110 108 110 112 110 110 110 100 116 110 108 116 116 102 110 110 116 The patient monitoring data collected by patient monitoring devicemay be sent wirelessly (e.g., WiFi, Bluetooth, MBAN) to one or more associated devices for processing, analysis, storage, display, etc., such as patient monitor, a central station, patient monitoring database, and/or different patient monitoring system. Patient monitoring devicemay include an antennato facilitate wireless transmission between patient monitoring deviceand the one or more associated devices. The methods of wireless communication used by patient monitoring deviceand the receiving systems vary widely based on the technology used. In one example communication approach, to facilitate the transfer of the patient monitoring data collected by patient monitoring device, patient monitoring environmentand nearby areas (e.g., hallways, closets, open spaces) may include one or more access points, which may receive from and send information (e.g., wirelessly) to patient monitoring device(e.g., the patient monitoring data, communication status). In some examples, patient monitormay include an access point. The access pointsends the received information to a processing server, a central station, a telemetry monitoring system, and/or another suitable device. If patientleaves the patient room and moves throughout the medical facility, patient monitoring data collected by patient monitoring devicemay be sent to other access points located throughout the medical facility. Patient monitoring data collected by patient monitoring devicemay likewise be sent to a processing and analysis server, the central station, the telemetry monitoring system, and/or another suitable device, via wireless communication with access pointor another access point, or via a wired connection. It is understood, this example using a transceiver and access point for data communications is one of many different technologies suitable for sharing acquired patient monitoring data with the associated data processing, analysis, storage, and information viewing system components and infrastructure.

2 FIG. 1 FIG. 1 FIG. 200 110 240 260 110 240 260 240 260 200 100 290 110 260 Referring now to, a patient monitoring systemis shown that includes patient monitoring deviceof, which may be connected to a servervia a wireless network. Patient monitoring devicemay send data (e.g., including physiological patient data) to serverover network, and receive data transmitted from serverover the network. In various embodiments, patient monitoring systemmay be established within a hospital environment or healthcare facility, such as patient monitoring environmentof. In some embodiments, a remote caregivermay view the patient data on patient monitoring deviceremotely in an office, research module, laboratory, or while moving around the hospital facility, also via network.

110 270 110 270 110 1 FIG. In some embodiments, patient monitoring devicemay include one or more sensing components, which may be housed within a same enclosure, which is positioned on a patient at a location where the patient is being monitored, as described above in reference to. For example, patient monitoring devicemay be located within the healthcare facility, and positioned such that the one or more sensing componentsare in contact with a skin of the patient at a bed of the hospital facility. The patient may wear various patient monitoring devices, each measuring different vital signs and each including their own microcontroller, battery, antenna etc.

270 110 270 270 270 270 The one or more sensing componentsmay be specially designed devices for sensing a certain type or types of patient data via placement on a patient's body, and communicating the patient data to patient monitoring device. The one or more sensing componentsmay further include a plurality of sensors of different types or the same type. The one or more sensing componentsmay be used to obtain physiological patient data from a patient. For example, the one or more sensing componentsmay include, but are not limited to, a 3-lead ECG sensor, a pulse oximetry sensor, a blood pressure sensor, a digital stethoscope, a respiratory sensor, a temperature sensor, and the like. The one or more sensing componentsmay include a combination of one or more different kinds of sensor.

270 270 270 The physiological patient data is alternatively referred to herein as patient data. The patient data may include, for example, vital signs of the patient, such as a blood pressure or a pulse, and/or any other type of data that may be acquired from a sensor capable of acquiring patient physiological patient data in real-time. Thus, the data sensed by the one or more sensing componentscorrelates to the type of sensors in one or more sensing componentsand may include ECG data, PPG data, blood pressure data, SpO2 data, respiratory rate, otoscope data, temperature data, and the like. It will be appreciated that the types of sensing components listed above are mentioned for illustrative purposes, and the one or more sensing componentsmay additionally include other types of sensors for obtaining physiological signal information of a patient without departing from the scope of this disclosure.

270 270 110 The patient data obtained from the one or more sensing componentsmay be acquired concurrently or selectively from one or more selected subsets of sensing components of the one or more sensing components. In some embodiments, different types of patient data may be acquired concurrently or selectively independent of each other. For example, patient monitoring devicemay acquire auscultation data (e.g., via a digital stethoscope) but no ECG data, or ECG data but no auscultation data. In other words, while audio and ECG sensors may both be present, auscultation or ECG data may be selectively obtained.

260 110 200 110 108 260 1 FIG. Networkmay include in a non-limiting manner, a wide area network (WAN); a local area network (LAN); the Internet; a wired or wireless (e.g. optical, Bluetooth, Bluetooth Low Energy (BLE), radio frequency (RF)) network; a cloud-based computer infrastructure of computers, routers, servers, gateways, etc.; or any combination thereof associated therewith that allows patient monitoring deviceto communicate with other components of patient monitoring system. In some examples, patient monitoring devicemay communicate with the other components via patient monitorof. Networkmay be or include a public network, or a private network associated with a portion of a care facility, for example a surgery module or department of a hospital, or may be more broadly located across medical devices of an entire hospital or hospital system.

110 270 270 110 260 110 200 In some embodiments, patient monitoring deviceand the one or more sensing componentsmay be communicatively coupled via a wireless personal area network (PAN) technology such as a Medical Body Area Network (MBAN). In other embodiments, any PAN technology may be used, such as induction wireless, infrared wireless, ultra wideband (UWB), Bluetooth®, or any other similar technology for wireless communication between co-located devices. For example, the one or more sensing componentsmay communicate with patient monitoring devicevia an MBAN network of network, and patient monitoring devicemay communicate with other elements of patient monitoring systemvia a WiFi network.

110 224 225 112 226 230 232 234 110 260 225 224 224 110 224 260 225 224 260 116 1 FIG. Patient monitoring devicemay include a transceiver, an antenna(e.g., antenna), a local data processing module, a processor, a memory, and a battery. Patient monitoring devicemay be adapted to receive data over the networkvia antennaand transceiver, such as sensor configuration and/or selection data. In some embodiments, the transceivermay be or may include a WLAN wireless card. In some embodiments, the WLAN card may be an original equipment manufacturer (OEM) card, and may include a storage medium having computer executable code and a processor to execute that code, thus effectuating the operation of the WLAN card. In another embodiment the tranciever may be a OEM radio module or system on chip. Patient monitoring devicemay use transceiverto connect to the networkvia antenna. For example, transceivermay connect to networkvia an access point of the network (e.g., access pointof) arranged at a location of the hospital environment, for example, in proximity to patients being monitored at a care module. The network may receive wirelessly transmitted information from the access point, and relay the information to one or more connected devices and/or a hospital information system suitable for collecting and managing such information.

110 230 230 110 226 270 230 260 230 232 110 232 232 Patient monitoring devicemay include a processor. The processormay control the operation of patient monitoring device. In some embodiments, a user may interact with local data processing moduleand adjust, configure, and/or select sensing componentsvia control signals sent to the processorvia network. The processormay execute instructions stored on a memoryto control patient monitoring device. As discussed herein, the memorymay include any non-transitory computer readable medium in which programming instructions are stored. For the purposes of this disclosure, the term “tangible computer readable medium” is expressly defined to include any type of computer readable storage. The example methods and systems may be implemented using coded instruction (e.g., computer readable instructions) stored on a non-transitory computer readable medium such as a flash memory, a read-only memory (ROM), a random-access memory (RAM), a cache, or any other storage media in which information is stored for any duration (e.g. for extended period time periods, permanently, brief instances, for temporarily buffering, and/or for caching of the information). Computer memory of computer readable storage mediums as referenced herein may include volatile and non-volatile or removable and non-removable media for a storage of electronic-formatted information such as computer readable program instructions or modules of computer readable program instructions, data, etc. that may be stand-alone or as part of a computing device. Examples of computer memory may include any other medium which can be used to store the desired electronic format of information and which can be accessed by the processor or processors or at least a portion of a computing device. In various embodiments, the memorymay include an SD memory card, an internal and/or external hard disk, USB memory device, or similar modular memory.

Program code embodied on a computer readable medium may be transmitted using any appropriate medium, including but not limited to wireless, wireline, optical fiber cable, RF, etc., or any suitable combination of the foregoing. Computer program code for carrying out operations for aspects of the present disclosure may be written in any combination of one or more programming languages, including an object oriented programming language such as Java, Smalltalk, C++ or the like and conventional procedural programming languages, such as the “C” programming language or similar programming languages. The program code may execute entirely on the user's computer, partly on the user's computer, as a stand-alone software package, partly on the user's computer and partly on a remote computer or entirely on the remote computer or server. In the latter scenario, the remote computer may be connected to the user's computer through any type of network, including a local area network (LAN) or a wide area network (WAN), or the connection may be made to an external computer (for example, through the Internet using an Internet Service Provider).

110 270 226 232 110 232 290 Upon being received at patient monitoring devicefrom the one or more sensing components, the patient data may be processed by local data processing module. Processing the patient data may include, for example, comparing values of the patient data with one or more threshold values stored in the memory. For example, patient monitoring devicemay include one or more lookup tables stored in the memorywith the one or more threshold values. During processing of the patient data, a threshold value of the one or more threshold values may be retrieved from the one or more lookup tables and compared to a corresponding value of the patient data. For example, if a blood pressure of the patient exceeds a threshold blood pressure (e.g., retrieved from the one or more lookup tables), a health status alert may be generated. In response to the health status alert being generated, an alarm may be generated, to be displayed to remote caregiver, for example.

260 250 200 240 240 290 290 240 110 270 240 260 226 242 240 In some embodiments, the patient data and/or results of any processing of the patient data (e.g., health status information) may be transmitted over the networkto one or more hospital information systemsof the patient monitoring system, via server. Servermay also serve the patient data and/or results to a wireless device of remote caregiver, so that the remote caregivermay view the patient data and/or results. Further, some or all of the processing of the patient data may be carried out at server. For example, under some conditions, the patient data received at patient monitoring devicefrom the one or more sensing componentsmay be transmitted to serverover the networkwithout being processed at local data processing module, and the patient data may be processed at a cloud data processing moduleof server.

225 225 110 225 110 110 As described in greater detail below, antennamay be a printed and thermoformed antenna. Additionally, antennamay be printed on and/or thermoformed into an enclosure in which patient monitoring deviceis housed. By printing and thermoforming antennain this manner, a size, weight, and a cost of patient monitoring devicemay be reduced with respect to alternative patient monitoring devices that rely on antennas formed out of sheet metal or other conventional antennas such as chip antennas or etched circuit board antennas. Because patient monitoring devicemay be a single use, disposable device that is used on a single patient in a single instance and then discarded, the reduction in the cost of the printed and thermoformed antenna may have a large impact on an overall cost of a hospital's patient monitoring demands.

3 FIG. 4 5 FIGS.and 6 8 FIGS.- 300 110 225 shows a high-level methodfor manufacturing a patient monitoring device such as patient monitoring device, using printed conductive ink and thermoforming to form an antenna such as antenna. Details of the manufacturing process are further elaborated upon in the methods of, and perspective views of the patient monitoring device at various stages of the manufacturing process are shown in.

302 300 4 FIG. In a first step, methodincludes printing a two-dimensional (2D) design of an antenna on a first substrate material using a conductive ink, thereby forming an electrical path or trace. The conductive ink may also be formed into a plurality of conductive traces through which a sensor of the patient monitoring device may electrically communicate with electrical components of the patient monitoring device such as a transceiver, which may be mounted on an integrated circuitry. Printing the conductive traces on the first substrate material is described in greater detail below in reference to.

304 300 5 FIG. In a second step, methodincludes thermoforming the printed first substrate material, or one or more portions of the printed first substrate material using a mold. Thermoforming the first substrate material may include various steps involving stretching the first substrate material and applying vacuum and/or pressure to the first substrate material, which are described in greater detail below in reference to.

306 300 108 After the printed, thermoformed first substrate material has cooled, at a third step, methodincludes coupling integrated circuitry, such as a printed circuit board, to a printed electrical trace of the first substrate material, such that electrical signals generated by the integrated circuitry and/or sensors of the patient monitoring device may be transmitted wirelessly to an external device (e.g., patient monitor) via an antenna formed by the printed conductive traces.

308 300 At a fourth stepof the method, methodincludes positioning the thermoformed first substrate material over the integrated circuitry and electronic components, and sealing the thermoformed first substrate material to a second substrate material on which the integrated circuitry has been positioned, to enclose the electrical components. Alternatively, the thermoformed first substrate material may be sealed directly to the integrated circuitry. For example, the integrated circuitry may include a printed circuit board, and the thermoformed first substrate material may be sealed to the printed circuit board. The thermoformed first substrate material may be sealed to the integrated circuitry or the second substrate material of the substrate using thermoplastic staking or ultrasonic welding, or using an adhesive or other means of sealing plastic edges of the first and/or second substrates. After the thermoformed first substrate material is sealed around the integrated circuitry, the electrical components may be protected from damage from fluids or contaminants present in the monitoring environment.

270 7 8 FIGS.- In some examples, the first substrate material may be the same as the second substrate material. That is, the first substrate material may be cut into a shape that allows one or more first portions of the first substrate material to be folded onto one or more second portions of the first substrate material, such that edges of the first portions may be aligned with edges of the second portions to facilitate sealing the first and second portions together. For example, the first substrate material may be divided into various sections, which may then be positioned in face-sharing contact after thermoforming. One or more sensors (e.g., sensing components) may be positioned at a first section; a printed circuit board, batteries, etc., may be positioned at a second section; a third section of the substrate material may be thermoformed to create the antenna. After thermoforming, the third section may then be positioned on top of the second section (e.g., folded) to enclose the integrated circuitry. An example of such a design is shown in.

4 FIG. 6 7 8 FIGS.,, and 3 FIG. 1 2 FIGS.and 400 610 400 300 110 Referring now to, a methodis shown for printing a conductive ink on a substrate material to form a printed antenna such as the printed antenna of conductive traceof. Methodmay be performed as part of methodof, by a manufacturer of a patient monitoring device such as patient monitoring deviceof.

400 402 400 700 Methodbegins at, where methodincludes screen printing a first layer of conductive ink on a substrate material, such as plastic film. Certain substrate materials may be more suitable than others. The substrate material may be a plastic film that can endure relatively high temperatures used for ink drying, while still being formable at a higher temperature. For example, an ideal ink may dry at 70° C. with no deformation, but still be thermoformable at 140°. For example, the substrate material may include polyethylene terephthalate glycol (PETG), polystyrene (PS) or high impact polystyrene (HIPS), ethylene-vinyl acetate (EVA) or a polycarbonate (PC) polymer. One advantage of the methods described herein is that the substrate material may be a bio-compatible material, where the bio-compatibility of the material is unaffected by the methods.

The conductive ink used may be selected based on a tolerance of the ink to stretching. In various embodiments, the conductive ink may be a silver-based ink. Screen printing the first layer of conductive ink further includes selecting a first mesh size of a screen printer, which may depend on the selected ink. In some embodiments, an inkjet printer, or a different ink dispensing method, may be used instead of or in addition to screen printing. As a result of the screen printing, one or more printed electrical traces with the conductive ink are positioned on the substrate material, where the printed electrical traces comprise an antenna used by a wireless transmitter to transmit data. The printed electrical traces of the conductive ink form a structure that is bonded to the plastic film, that can be detected or inspected.

404 400 At, methodincludes drying the layer. For example, drying the layer may include exposing the ink of the first layer of conductive ink to a suitable temperature to dry the ink without deformation. In one example, the suitable temperature is 70°. When the ink is dried, solvents in the ink may be vaporized. However, the ink may not be cured during the drying process, as fully cured inks may be more resistant to thermoforming.

406 400 At, methodincludes screen printing a second layer of conductive ink on the substrate material. The second layer of conductive ink may be printed at the same location(s) on the substrate material as the first layer of conductive ink (e.g., on top of the first layer). The conductive ink used in the second layer may be the same as the conductive ink used in the first layer, or a different conductive ink may be used. Printing a plurality of layers of ink on top of each other may make the conductive traces more tolerant to thermoforming. That is, a first conductive trace comprising a plurality of layers of ink may stretch during the thermoforming process and not break, while a second conductive trace comprising a single layer of ink may break during the thermoforming process. Screen printing the second layer of conductive ink further includes selecting a second mesh size of the screen printer, which may be different from the first mesh size. Using different sized meshes for printing different layers may result in a more robust conductive trace that is more prone to stretching and less prone to breaking.

408 400 400 400 400 400 At, methodincludes drying the ink of the second layer of conductive ink at the suitable temperature, as described above, and methodends. However, it should be appreciated that while for simplicity methodincludes applying two layers of conductive ink, in other embodiments, a greater number of layers of conductive ink may be printed on the substrate material in accordance with method. Additionally or alternatively, additional dielectric layers may be printed on top of the conductive traces of the first and/or second layers of conductive ink, which may lead to better thermoforming results. The dielectric layers can be printed in selected locations to stiffen specific sections during the thermoforming, allowing some areas to stretch more, and some areas to stretch less during the forming phase. The dielectric layers may also be printed to insulate the conductive layers, for example, to avoid short circuiting of battery cells inside the hollow dome space. Methodends.

5 FIG. 8 FIG. 7 FIG. 3 FIG. 500 110 800 500 300 500 Referring now to, a methodis shown for thermoforming a substrate material on which a conductive trace has been printed to form an enclosure a patient monitoring device, such as patient monitoring deviceand/or patient monitoring deviceof. By thermoforming the substrate material, the substrate material may be formed into a hollow shape that may be used to enclose an integrated circuitry and/or other associated electronics of the patient monitoring device, such as integrated circuitry of. Methodmay be performed as part of methoddescribed above in reference to. It should be appreciated that in some embodiments, one or more steps of methodmay be omitted, or performed in a different order.

500 502 500 Methodbegins at, where methodincludes heating the substrate material to a threshold temperature. The threshold temperature may be higher than a material glass transition temperature, and a temperature at which the substrate material may be stretched without rupturing, using a mold. For example, the threshold temperature may be 140°. The heating of the substrate material may be performed within a threshold duration, such as five seconds. The heating phase of the thermoforming process may be conducted as quickly as possible, to minimize an effect of curing the ink prior to stretching the substrate material, which may make the ink more resistant to stretching.

504 500 At, methodincludes stretching the substrate material over a mold. A size of the mold may be selected based on a size of the integrated circuitry and/or electrical components enclosed within the patient monitoring device. Additionally, a shape of the mold may be designed to facilitate stretching. The mold may be designed such that an elongation of the substrate material is reduced or minimized in printed areas of the substrate material, to reduce a possibility of the printed conductive traces breaking. For example, the mold may be selected from a plurality of molds, where each mold of the plurality of molds is designed for a set of conductive traces or pathways. For each antenna design, a corresponding mold may be selected, where the corresponding mold may have differently shaped portions for areas of the substrate material including conductive traces and areas of the substrate material not including the conductive traces. In this way, when the substrate material is stretched over the selected mold, the areas including the conductive traces may be stretched less than the areas not including the conductive traces.

Additionally, the mold may be selected based on a polarity of the mold. For example, a positive mold may be selected over a negative mold, as the positive mold may result in less stretching than the negative mold. Also, depending on the polarity, the printed traces can be selected to either face towards or away from a surface of the mold. The facing will impact whether the conductive traces are inside or outside the dome substrate, but the stretching of the printed traces may also be different.

506 500 508 500 At, methodincludes applying a vacuum suction through and around the mold under the substrate. The vacuum suction draws the substrate around the mold. At, methodoptionally includes applying a pressure on top of the substrate material and the mold. Applying the pressure may include holding the pressure for a threshold duration, to ensure that the ink is fully cured and the forming is finished. In one example, the threshold duration is 60 seconds.

510 500 500 At, methodincludes cooling the thermoformed substrate material and the mold, and methodends. Thus, the substrate material may be formed into a desired shape (e.g., of the mold) in three stages, which may be performed sequentially. In the first stage, the substrate material is mechanically stretched; in the second stage, the substrate material is formed by the vacuum; and in the third stage, the substrate material is formed by over-pressure forming. By performing the three stages sequentially, a stretching of the area of the printed conductive trace may be minimized. However, in other embodiments, two or more of the three stages may be performed concurrently.

6 FIG. 600 602 610 633 300 602 610 630 631 630 631 610 Turning now to, an exemplary antenna diagramshows an antenna, which is created by printing a conductive traceon a substrate, in accordance with method. Antennais a loop antenna, where conductive traceforms a closed loop starting from a first endand ending at a second end, where first endand second endmay be connected to integrated circuitry of a sensing device as described above. However, in other embodiments, conductive tracemay form a different antenna design, such as a dipole, monopole, F antenna, planar inverted F antenna, or other antenna geometry.

602 610 650 651 652 650 652 650 651 The printed antennaformed by conductive tracemay form a meandering loop that includes a plurality of protruding rectangular sections, which may be separated by a plurality of recessed sectionsby a distance. In other embodiments, the number of protruding rectangular sectionsmay be different, and/or the distancebetween the protruding rectangular sectionsand the recessed sectionsmay be different.

602 300 604 633 610 610 607 610 606 604 609 610 608 604 611 608 613 606 610 633 6 FIG. Thermoforming antenna(e.g., in accordance with method) may result in a thermoformed antenna, where substrateis stretched and molded to form an enclosure for components of a device, such as a patient monitoring device. Portions of conductive tracemay be stretched, while other portions of conductive tracemay be stretched. In, a first, meandering sideof conductive traceforms a printed electrical pathat a top of the enclosure of thermoformed antennathat is not stretched. Alternatively, a straight sideof conductive traceforms a printed electrical pathat a side of the enclosure of thermoformed antennathat is stretched such that a first width (height)of printed electrical pathis greater than a second widthof printed electrical path. Thus, characteristics of a printed electronic path forming an antenna for the enclosed circuitry depend on where conductive traceis positioned on substrate.

610 An advantage of this antenna design is that the shape and positioning of conductive tracecan be simply variated by modifying the printing screen and custom designed to be ideal for internal circuitry of an associated device. The associated device could also include batteries under the dome to power the device and they would impact the design of the antenna. A fairly complex antenna design can by these means be created using existing simple machinery, namely screen printing and thermoforming equipment.

7 8 FIGS.and 604 show an exemplary configuration of a patient monitoring device enclosed in a thermoformed antenna such as antenna, before and after thermoforming.

7 FIG. 6 FIG. 700 700 700 702 704 706 602 Referring to, an exemplary plastic filmcomprising a 2D sheet of substrate material is shown, which has a suitable shape for incorporating one or more sensors and an integrated circuitry during assembly. While plastic filmis depicted as having been cut to form the suitable shape, in practice plastic filmmay be cut after thermoforming has been performed. The suitable shape has three sections: a first sectionin which one or more sensors may be positioned; a second sectionin which an integrated circuitry may be positioned; and a third sectionincluding a printed antenna, which may be the same as or similar to antennaof. In other embodiments, the suitable shape may be different, and may include different sections, and/or a different number of sections.

702 700 712 716 702 712 716 712 716 715 712 716 702 715 712 716 712 716 7 FIG. First sectionof plastic filmincludes a first portionon which the one or more sensors may be placed, and a second portionwhich may form a top portion of an enclosure of the one or more sensors. In other examples, sensing elements may sit directly on a printed circuit board assembly, and first sectionmay not be included. In, first portionand second portionhave a circular shape of an identical or similar size. In other embodiments, first portionand second portionmay have a different shape, such as a rectangular, square, oval, or other shape. A diameter, or a size of first portionand second portionmay depend on a size of the one or more sensors positioned at section. That is diameter(the size) may be larger than a diameter or size of the one or more sensors, such that when the one or more sensors are placed on first portionand enclosed by second portion, edges of first portionand second portionmay be in face-sharing contact around the one or more sensors, to facilitate sealing the one or more sensors at the edges.

712 716 713 716 712 712 716 712 712 716 717 712 718 716 717 718 702 5 FIG. In various embodiments, first portionmay be connected to second portionvia a connector portion, such that second portionmay be folded and placed on top of first portionafter the one or more sensors have been positioned on first portion. Further, in some examples, second portionmay be thermoformed as described below in reference tointo a hollow, non-flat or domed shape, which may be positioned on top of first portion, with the one or more sensors arranged between first portionand second portionwithin the hollow domed shape. A first circumferential edgealong a perimeter of first portionmay be in face sharing contact with a second circumferential edgealong a perimeter of second portion. First circumferential edgemay be coupled to second circumferential edgeto seal first sectionaround the one or more sensors, using thermoplastic staking, ultrasonic welding, or a different method.

708 702 704 720 721 708 702 708 704 722 723 740 704 A first printed electrical pathmay connect the one or more sensors of first sectionto an integrated circuitry positioned at or on section. The one or more sensors may be electrically connected to a first terminaland a second terminalof first printed electrical pathat first section. The integrated circuitry may be electrically connected to first printed electrical pathat second sectionvia a third terminaland a fourth terminalat a first sideof second section.

710 704 706 710 724 725 741 704 A second printed electrical pathmay connect to the integrated circuitry at section, and may form the printed antenna at third section. The integrated circuitry may be electrically connected to the second printed electrical pathvia a fifth terminaland a sixth terminalat a second sideof second section.

5 FIG. 706 710 704 706 704 730 700 706 704 706 704 706 732 704 733 706 732 733 706 704 In accordance with the method of, third sectionmay be thermoformed, after second printed electrical pathhas been printed, into a hollow shape that may enclose the integrated circuitry in second section. That is, third sectionmay be attached to second sectionvia a connector portionof plastic film, such that third sectionmay be folded and/or placed on top of second section, after third sectionis thermoformed, with the integrated circuitry sandwiched between second sectionand third section. A first edgealong a perimeter of second sectionmay be in face sharing contact with a second edgealong a perimeter of third section. First edgemay be coupled to second edgeto seal the integrated circuitry between third sectionand second section, using thermoplastic staking, ultrasonic welding, or a different method.

8 FIG. 7 FIG. 8 FIG. 800 700 706 732 704 733 706 704 722 723 740 724 725 741 shows a perspective view of a fully formed patient monitoring devicecreated using plastic film, after manufacturing. The thermoformed, printed antenna at third sectionofforms an enclosure that has been positioned (e.g., folded) on top of integrated circuitry (not shown in), such that first edgeof second sectionand second edgeof third sectionare sealed in face sharing contact, thereby protecting the integrated circuitry and associated electronics from contact with external elements. That is, the integrated circuitry has been positioned at second sectionof the substrate, in electronic communication with third terminaland fourth terminalat first sideand with fifth terminaland sixth terminalat second side. The associated electronics may include battery cells that power the device, which may be protected by the sealed shape.

802 712 702 720 721 716 702 712 717 712 718 716 802 802 Similarly, a sensing electrical component (e.g., a photodetector)has been positioned at first portionof first sectionand attached to first terminaland second terminal. Second portionof first sectionforms an enclosure that has been positioned (e.g., folded) on top of first portion, such that first circumferential edgeof first portionand second circumferential edgeof second portionare sealed in face sharing contact, thereby protecting photodetectorand associated electronics from contact with external elements. Photodetectormay be used as part of a pulse oximetry measurement, for example.

Further, in some examples, electrical components and chips may be assembled directly on a screen printed substrate, further reducing a cost and increasing an efficiency of manufacturing. Printed electronics is a well-known technology that could be combined with thermoforming to further save cost and reduce complexity by eliminating a reliance on a separate circuit board.

As described above, the methods described herein may be used to manufacture various types of patient monitoring and/or sensing devices, in particular, where lightweight antennas are desired to be customized to a specific task, technology or patient and the cost of such customization may be high for alternative types of metal antennas. As another example, methods 3, 4, and 5 may be used to manufacture customizable MRI measurement coils that may be used to measure the realigning of protons after gradient stimulation during an MR imaging scan from within an MRI machine. In other words, in an MR application, the antenna functions not as a data transmission antenna as with a patient monitoring device, but rather as an imaging antenna. Due to the nature of MRI technologies, to get sharp and detailed MR images, it may be desired that a measurement coil be tightly fitted around a portion of the patient being scanned. In such situations, a printed and thermoformed antenna may be created that meets the demands for such a close fit more efficiently and inexpensively than alternative options.

0 0 0 10 FIG. Magnetic resonance imaging (MRI) is a medical imaging modality that can create images of the inside of a human body without using x-rays or other ionizing radiation. MRI systems include a superconducting magnet to create a strong, uniform, static magnetic field B. When a human body, or part of a human body, is placed in the magnetic field B, the nuclear spins associated with the hydrogen nuclei in tissue water become polarized, wherein the magnetic moments associated with these spins become preferentially aligned along the direction of the magnetic field B, resulting in a small net tissue magnetization along that axis. MRI systems also include gradient coils that produce smaller amplitude, spatially-varying magnetic fields with orthogonal axes to spatially encode the magnetic resonance (MR) signal by creating a signature resonance frequency at each location in the body. The hydrogen nuclei are excited by a radio frequency signal at or near the resonance frequency of the hydrogen nuclei, which add energy to the nuclear spin system. As the nuclear spins relax back to their rest energy state, they release the absorbed energy in the form of an RF signal. This RF signal (or MR signal) is detected by one or more measurement coils placed tightly around the body (also referred to herein as RF coil units) and transmitted to a computer for processing, where the RF signal is transformed into the image using reconstruction algorithms. The RF signal may be received using a thermoformed antenna, as described below in reference to.

9 FIG. 910 912 913 914 915 920 922 923 924 925 926 931 932 933 914 916 915 914 915 914 910 916 918 916 916 illustrates a magnetic resonance imaging (MRI) apparatusthat includes a magnetostatic field magnet unit, a gradient coil unit, an RF coil unit, an RF body coil unit, a transmit/receive (T/R) switch, an RF driver unit, a gradient coil driver unit, a data acquisition unit, a controller unit, a patient table or bed, a data processing unit, an operating console unit, and a display unit. In some embodiments, the RF coil unitis a surface coil, which is a local coil typically placed proximate to the anatomy of interest of a subject. Herein, the RF body coil unitis a transmit coil that transmits RF signals, and the local surface RF coil unitreceives the MR signals. As such, the transmit body coil (e.g., RF body coil unit) and the surface receive coil (e.g., RF coil unit) are separate but electromagnetically coupled components. The MRI apparatustransmits electromagnetic pulse signals to the subjectplaced in an imaging spacewith a static magnetic field formed to perform a scan for obtaining magnetic resonance signals from the subject. One or more images of the subjectcan be reconstructed based on the magnetic resonance signals thus obtained by the scan.

912 916 0 The magnetostatic field magnet unitincludes, for example, an annular superconducting magnet, which is mounted within a toroidal vacuum vessel. The magnet defines a cylindrical space surrounding the subjectand generates a constant primary magnetostatic field B.

910 913 918 913 913 916 915 916 913 916 913 916 The MRI apparatusalso includes a gradient coil unitthat forms a gradient magnetic field in the imaging spaceso as to provide the magnetic resonance signals received by the RF coil arrays with three-dimensional positional information. The gradient coil unitincludes three gradient coil systems, each of which generates a gradient magnetic field along one of three spatial axes perpendicular to each other, and generates a gradient field in each of a frequency encoding direction, a phase encoding direction, and a slice selection direction in accordance with the imaging condition. More specifically, the gradient coil unitapplies a gradient field in the slice selection direction (or scan direction) of the subject, to select the slice; and the RF body coil unitor the local RF coil arrays may transmit an RF pulse to a selected slice of the subject. The gradient coil unitalso applies a gradient field in the phase encoding direction of the subjectto phase encode the magnetic resonance signals from the slice excited by the RF pulse. The gradient coil unitthen applies a gradient field in the frequency encoding direction of the subjectto frequency encode the magnetic resonance signals from the slice excited by the RF pulse.

914 916 914 918 912 915 925 916 916 914 916 914 914 0 1 The RF coil unitis disposed, for example, to enclose the region to be imaged of the subject. In some examples, the RF coil unitmay be referred to as the surface coil or the receive coil. In the static magnetic field space or imaging spacewhere a static magnetic field Bis formed by the magnetostatic field magnet unit, the RF body coil unittransmits, based on a control signal from the controller unit, an RF pulse that is an electromagnet wave to the subjectand thereby generates a high-frequency magnetic field B. This excites a spin of protons in the slice to be imaged of the subject. The RF coil unitreceives, as a magnetic resonance signal, the electromagnetic wave generated when the proton spin thus excited in the slice to be imaged of the subjectreturns into alignment with the initial magnetization vector. In some embodiments, the RF coil unitmay transmit the RF pulse and receive the MR signal. In other embodiments, the RF coil unitmay be used for receiving the MR signals, but not transmitting the RF pulse.

915 918 912 918 914 910 915 910 914 916 915 915 916 914 916 914 915 0 The RF body coil unitis disposed, for example, to enclose the imaging space, and produces RF magnetic field pulses orthogonal to the main magnetic field Bproduced by the magnetostatic field magnet unitwithin the imaging spaceto excite the nuclei. In contrast to the RF coil unit, which may be disconnected from the MRI apparatusand replaced with another RF coil unit, the RF body coil unitis fixedly attached and connected to the MRI apparatus. Furthermore, whereas local coils such as the RF coil unitmay be configured to transmit to or receive signals from a localized region of the subject, the RF body coil unitgenerally has a larger coverage area. For example, the RF body coil unitmay be used to transmit or receive signals to the whole body of the subject, and the RF coil unitmay be configured to transmit or receive signals from a specific anatomy of the subject, such as a limb, or an organ. Using receive-only local coils and transmit body coils provides a uniform RF excitation and good image uniformity at the expense of high RF power deposited in the subject. For a transmit-receive local coil, the local coil provides the RF excitation to the region of interest and receives the MR signal, thereby decreasing the RF power deposited in the subject. It should be appreciated that the particular use of the RF coil unitand/or the RF body coil unitdepends on the imaging application.

916 914 917 916 917 917 917 917 To transmit to or receive signals from the localized region of the subject, RF coil unitmay be configured to include an RF antenna. The RF antenna may be thermoformed as described herein to more closely follow a contour of a portion of an anatomy of the subject. For example, the RF antennamay be thermoformed to wrap around a torso, head, leg, foot, etc. of the patient. By thermoforming the RF antenna, a distance between the RF antennaand the body of the patient may be reduced, resulting in sharper and more detailed images. Additionally, a thermoformed RF antennamay be lighter and less expensive to manufacture/assemble than other types of RF antennas currently in use.

920 915 924 922 920 914 924 914 922 914 915 914 915 920 922 915 914 924 915 914 The T/R switchcan selectively electrically connect the RF body coil unitto the data acquisition unitwhen operating in receive mode, and to the RF driver unitwhen operating in transmit mode. Similarly, the T/R switchcan selectively electrically connect the RF coil unitto the data acquisition unitwhen the RF coil unitoperates in receive mode, and to the RF driver unitwhen operating in transmit mode. When the RF coil unitand the RF body coil unitare both used in a single scan, for example if the RF coil unitis configured to receive MR signals and the RF body coil unitis configured to transmit RF signals, then the T/R switchmay direct control signals from the RF driver unitto the RF body coil unitwhile directing received MR signals from the RF coil unitto the data acquisition unit. The coils of the RF body coil unitmay be configured to operate in a transmit-only mode or a transmit-receive mode. The coils of the local RF coil unitmay be configured to operate in a transmit-receive mode or a receive-only mode.

922 915 918 922 925 915 The RF driver unitincludes a gate modulator (not shown), an RF power amplifier (not shown), and an RF oscillator (not shown) that are used to drive the RF coils (e.g., RF body coil unit) and form a high-frequency magnetic field in the imaging space. The RF driver unitmodulates, based on a control signal from the controller unitand using the gate modulator, the RF signal received from the RF oscillator into a signal of predetermined timing having a predetermined envelope. The RF signal modulated by the gate modulator is amplified by the RF power amplifier and then output to the RF body coil unit.

923 913 925 918 923 913 The gradient coil driver unitdrives the gradient coil unitbased on a control signal from the controller unitand thereby generates a gradient magnetic field in the imaging space. The gradient coil driver unitincludes three systems of driver circuits (not shown) corresponding to the three gradient coil systems included in the gradient coil unit.

924 914 924 922 914 931 The data acquisition unitincludes a pre-amplifier (not shown), a phase detector (not shown), and an analog/digital converter (not shown) used to acquire the magnetic resonance signals received by the RF coil unit. In the data acquisition unit, the phase detector phase detects, using the output from the RF oscillator of the RF driver unitas a reference signal, the magnetic resonance signals received from the RF coil unitand amplified by the pre-amplifier, and outputs the phase-detected analog magnetic resonance signals to the analog/digital converter for conversion into digital signals. The digital signals thus obtained are output to the data processing unit.

910 926 916 916 918 926 925 The MRI apparatusincludes a tablefor placing the subjectthereon. The subjectmay be moved inside and outside the imaging spaceby moving the tablebased on control signals from the controller unit.

925 925 932 932 926 922 923 924 925 931 933 932 The controller unitincludes a computer and a recording medium on which a program to be executed by the computer is recorded. The program when executed by the computer causes various parts of the apparatus to carry out operations corresponding to pre-determined scanning. The recording medium may comprise, for example, a ROM, flexible disk, hard disk, optical disk, magneto-optical disk, CD-ROM, or non-volatile memory card. The controller unitis connected to the operating console unitand processes the operation signals input to the operating console unitand furthermore controls the table, RF driver unit, gradient coil driver unit, and data acquisition unitby outputting control signals to them. The controller unitalso controls, to obtain a desired image, the data processing unitand the display unitbased on operation signals received from the operating console unit.

932 932 925 The operating console unitincludes user input devices such as a touchscreen, keyboard and a mouse. The operating console unitis used by an operator, for example, to input such data as an imaging protocol and to set a region where an imaging sequence is to be executed. The data about the imaging protocol and the imaging sequence execution region are output to the controller unit.

931 931 925 925 931 924 924 The data processing unitincludes a computer and a recording medium on which a program to be executed by the computer to perform predetermined data processing is recorded. The data processing unitis connected to the controller unitand performs data processing based on control signals received from the controller unit. The data processing unitis also connected to the data acquisition unitand generates spectrum data by applying various image processing operations to the magnetic resonance signals output from the data acquisition unit.

933 925 933 932 933 916 31 1000 1050 910 1000 1001 1002 1003 1050 1000 1005 914 1004 1001 1005 1004 1005 1005 1004 1004 1001 1003 1005 1001 1002 1050 1005 1005 1005 1005 10 FIG. 9 FIG. The display unitincludes a display device and displays an image on the display screen of the display device based on control signals received from the controller unit. The display unitdisplays, for example, an image regarding an input item about which the operator inputs operation data from the operating console unit. The display unitalso displays a two-dimensional (2D) slice image or three-dimensional (3D) image of the subjectgenerated by the data processing unit.shows an imageof an MRI apparatussuch as MRI apparatusof. In image, a patientis positioned on a tablein preparation for insertion into a cavityof MRI apparatus. In image, an RF coil unit(e.g., RF coil unit) is arranged around a legof patient. RF coil unitmay be used as an imaging antenna to measure the realigning of protons after gradient stimulation of legduring an MR imaging scan. In contrast to current RF coil units, a screen-printed, thermoformed RF coil unitmay be lighter and thinner, such that RF coil unitmay be advantageously positioned on or coupled to legin a manner that occupies a very small amount of the space available around legwhen patientis positioned within cavity. As a result, an interference of RF coil unitwith patientand other components of tableand/or MRI apparatusmay be reduced or minimized with respect to other wired or wireless solutions. Further, by screen printing and thermoforming RF coil unit, a cost of RF coil unitmay be reduced. Reducing the cost of the RF coil unitmay enable the manufacturing of disposable RF coil unitsthat can be custom-fit to an anatomy of a patient or set of patients. As a result of having a tighter, more customized coil, image quality may be increased. Additionally, an imaging sequence may be shortened, which is valuable for MRI usage since a throughput of patients can be increased. An additional benefit is that due to the reduction in costs, coils of various sizes may be created, which may increase the image quality for patients of different sizes and shapes. Further, a comfort of a patient may be increased by using a simpler and more light weight coil, particularly with respect to head coils.

Thus, systems and methods are described herein for manufacturing optimized, low-cost antenna solutions that enable low-cost, disposable devices to communicate wirelessly with patient monitoring systems and/or other receiving computer systems. For example, the methods have been developed for use with patient monitoring sensors such as pulse oximetry, body temperature, electrocardiographic and respiratory rate sensors, and MRI customized measurement coil units. The methods provide a solution for cost effectively manufacturing customized antenna geometries in high volumes not feasible with conventional antenna designs. By screen printing and thermoforming the antennas, it is possible to create antenna geometries including but not limited to dipole, monopole and loop antennas. The antennas may be incorporated into an enclosure used to house and protect electrical components of the patient monitoring sensors, thereby reducing an amount of parts and material used to manufacture the antennas, in comparison with conventional or alternative antenna designs and materials. The antennas may also be thermoformed to follow a contour of a surface, such as a surface of a patient anatomy in an MR machine, to generate sharper and more detailed MR images of the patient anatomy.

The electrical two-dimensional path of the screen printed antenna may be formed with a conductive ink (such as a silver ink) on a thermoformable plastic sheet (such as polycarbonate, polystyrene or polyethylene terephthalate). After printing, the ink may be cured or partially cured, or left completely uncured before the thermoforming phase, where in the latter cases the heat of the thermoforming process will cure the printed ink. During the thermoforming phase, the sheet may be heated and stretched over a mold, after which a vacuum is pumped underneath the heated sheet and an over-pressure may be applied on the top side of the sheet to further improve the forming accuracy. In this way, patient monitoring demands of a hospital or health care system may be met in a cost-effective manner, and with a greater degree of customization than is feasible using conventional antenna designs. Further, the greater degree of customization may facilitate more accurate measurements of physiological, diagnostic, and/or imaging signal information, leading to more accurate diagnoses and improved patient outcomes. Specifically, patient outcomes may be improved by increasing the coverage of vital signs monitoring within the hospital, while still enabling patient mobility to support recovery. Mobility is enabled by wireless monitoring and body-worn sensors, which benefit from a small size and light weight, where the low cost of thermoforming makes it an accessible technology for a larger portion of the patients. Further, in some examples, the thermoformed devices/antennas described herein may be used in home care, meaning, outside hospital premises. In such cases the antenna could be a cellular, LTE, BLUETOOTH, NFC, or 5G antenna.

The technical effect of screen-printing and thermoforming an antenna on a plastic sheet is that a cost of manufacturing the antenna may be less than a cost of conventional or alternative antenna designs, and a degree of customization of the antenna to a patient, task, or technology may be increased, resulting in more accurate measurements of physiological, diagnostic, and/or imaging signal information. Thermoformed antennas may be lighter and of a smaller size, where a substrate simultaneously functions as an enclosure, whereby materials can be environmentally friendly and recyclable (or at least friendlier than conventional PCB antenna manufacturing). The high-level and simplicity of customization may enable more specialized purpose intended antennas that create better wireless links than a generic antenna. This in turn may enable lower RF power and less power consumption in the device.

The disclosure also provides support for a method for manufacturing a medical device, the method comprising: printing an electrical path on a substrate material using a conductive ink, thermoforming a section of the substrate material including the electrical path using a mold, to create a non-flat shape, and electrically connecting the electrical path to integrated circuitry of the medical device, wherein the electrical path included on the thermoformed section of the substrate material comprises an antenna relied on by the integrated circuitry to transmit or receive physiological, diagnostic, and/or imaging signal information. In a first example of the method, the medical device is a wireless patient monitoring device including a sensor that acquires physiological signal information. In a second example of the method, optionally including the first example, the medical device is a measurement coil of a magnetic resonance imaging (MRI) apparatus, the measurement coil thermoformed to follow a contour of a surface of a body of a subject of the MRI apparatus. In a third example of the method, optionally including one or both of the first and second examples, the method further comprises: positioning the integrated circuitry of the wireless patient monitoring device between the thermoformed section of the substrate material and a non-thermoformed portion of the wireless patient monitoring device, and sealing the thermoformed section and the non-thermoformed portion to enclose the integrated circuitry, wherein the non-thermoformed portion of the wireless patient monitoring device is one of: a non-thermoformed section of the substrate material, a non-thermoformed section of a second substrate material, and a printed circuit board of the integrated circuitry. In a fourth example of the method, optionally including one or more or each of the first through third examples, the thermoformed section and the non-thermoformed portion are sealed using one of an adhesive, thermoplastic staking, and ultrasonic welding. In a fifth example of the method, optionally including one or more or each of the first through fourth examples, printing the electrical path on the substrate material using the conductive ink further comprises: screen-printing a first layer of conductive ink on the substrate material, drying the first layer at a first threshold temperature, screen-printing a second layer of conductive ink on the substrate material on top of the first layer, and drying the second layer at the first threshold temperature. In a sixth example of the method, optionally including one or more or each of the first through fifth examples, the method further comprises: printing one or more additional dielectric layers on top of the conductive ink of the first and/or second layers of conductive ink. In a seventh example of the method, optionally including one or more or each of the first through sixth examples, thermoforming the section of the substrate material including the electrical path using the mold further comprises: heating the substrate material to a second threshold temperature, stretching the substrate material over the mold, in a first thermoforming stage, applying a vacuum suction through and around the mold at a first side of the substrate material, in a second thermoforming stage, and applying a pressure at a second, opposite side of the substrate material, in a third thermoforming stage. In a eighth example of the method, optionally including one or more or each of the first through seventh examples, the first thermoforming stage, the second thermoforming stage, and the third thermoforming stage are performed either concurrently or sequentially. In a ninth example of the method, optionally including one or more or each of the first through eighth examples, the mold is selected from a plurality of molds based on the printed electrical path, the mold having differently shaped portions for areas of the printed electrical path and areas of the substrate material not including the printed electrical path, such that when the substrate material is stretched over the selected mold, the areas including the printed electrical path may be stretched less than the areas not including the printed electrical path. In a tenth example of the method, optionally including one or more or each of the first through ninth examples, the substrate material is one of polyethylene terephthalate glycol (PETG), polystyrene or high impact polystyrene (HIPS), ethylene-vinyl acetate, and a polycarbonate (PC) polymer, and the conductive ink is a silver-based ink.

The disclosure also provides support for a wireless patient monitoring device, comprising: an integrated circuitry including a sensing component and a wireless transmitter, wherein the integrated circuitry is enclosed in a plastic film on which one or more printed electrical traces with a conductive ink are positioned, where the printed electrical traces comprise an antenna used by the wireless transmitter to transmit data acquired by the sensing component to a wireless receiver outside the wireless patient monitoring device. In a first example of the system, the plastic film enclosing the integrated circuitry is thermoformed to create a hollow, domed shape in which the integrated circuitry is enclosed. In a second example of the system, optionally including the first example, the sensing component is enclosed within a second thermoformed portion of the plastic film. In a third example of the system, optionally including one or both of the first and second examples, the wireless patient monitoring device is manufactured in a plurality of stages, including: a first stage in which the one or more printed electrical traces are printed on a substrate material in the conductive ink, a second stage in which a section of the substrate material including the one or more printed electrical traces comprising the antenna is heated and mechanically stretched using a mold, a third stage in which a vacuum is applied through and around the mold at a first side of the substrate material, and a fourth stage in which the integrated circuitry is coupled to, enclosed, and sealed by a thermoformed portion of the substrate material created by the second and third stages. In a fourth example of the system, optionally including one or more or each of the first through third examples, the third stage further comprises applying a pressure at a second, opposite side of the substrate material. In a fifth example of the system, optionally including one or more or each of the first through fourth examples in which the substrate material includes a first foldable portion that may be folded over the sensing component to enclose the sensing component, and a second foldable portion that may be folded over the integrated circuitry to enclose the integrated circuitry. In a sixth example of the system, optionally including one or more or each of the first through fifth examples, the mold is configured such that when the substrate material is stretched over the mold, some portions of the one or more printed electrical traces are stretched more than other portions of the one or more printed electrical traces.

The disclosure also provides support for a wireless radio-frequency (RF) coil unit of a magnetic resonance imaging (MRI) machine, comprising: a substrate material on which one or more printed electrical traces of a conductive ink are positioned, wherein the one or more printed electrical traces comprise an imaging antenna that measures a realigning of protons within a portion of an anatomy of a subject of the MRI machine after gradient stimulation of the portion during an MR imaging scan, the substrate material thermoformed to follow a contour of a surface of the portion of the anatomy. In a first example of the system, the wireless RF coil unit is customized to the subject.

When introducing elements of various embodiments of the present disclosure, the articles “a,” “an,” and “the” are intended to mean that there are one or more of the elements. The terms “first,” “second,” and the like, do not denote any order, quantity, or importance, but rather are used to distinguish one element from another. The terms “comprising,” “including,” and “having” are intended to be inclusive and mean that there may be additional elements other than the listed elements. As the terms “connected to,” “coupled to,” etc. are used herein, one object (e.g., a material, element, structure, member, etc.) can be connected to or coupled to another object regardless of whether the one object is directly connected or coupled to the other object or whether there are one or more intervening objects between the one object and the other object. In addition, it should be understood that references to “one embodiment” or “an embodiment” of the present disclosure are not intended to be interpreted as excluding the existence of additional embodiments that also incorporate the recited features.

In addition to any previously indicated modification, numerous other variations and alternative arrangements may be devised by those skilled in the art without departing from the spirit and scope of this description, and appended claims are intended to cover such modifications and arrangements. Thus, while the information has been described above with particularity and detail in connection with what is presently deemed to be the most practical and preferred aspects, it will be apparent to those of ordinary skill in the art that numerous modifications, including, but not limited to, form, function, manner of operation and use may be made without departing from the principles and concepts set forth herein. Also, as used herein, the examples and embodiments, in all respects, are meant to be illustrative and should not be construed to be limiting in any manner.